Atopic DermatitisPhase 3ROCKET-VOYAGERNCT05899816

A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis and Moderate-to-severe Atopic Dermatitis, run by Amgen at 85 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objectives of this study are to: estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24 Read more about this study

Who is it for?: Ages 18 to 54 years
Conditions the study is for: Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
What is being tested?: Rocatinlimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 221 participants
Where: 85 sitesin 2 countries
Study dates: 7 Jun 2023to 14 Nov 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 54 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months
History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)
Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3

Who cannot join

Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
Systemic corticosteroids
Systemic immunosuppressants
Phototherapy
Janus kinase inhibitors

Show all 14Show fewer

Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
TCS of any potency
Topical calcineurin inhibitors (TCI)
Topical Phosphodiesterase-4 inhibitors (PDE4)
Other topical immunosuppressive agents
Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents
Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization.
Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Trial locations and contacts

85 sites in 2 countries.

Country

City, postcode or hospital

85 sites in 2 countries

United States72 sites

University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Hamilton Research, LLC
Alpharetta, Georgia, 30022
Divine Dermatology and Aesthetics
Atlanta, Georgia, 30315
MetroDerm / Atlanta Center for Clinical Research, LLC
Atlanta, Georgia, 30342
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Kern Research Inc
Bakersfield, California, 93301
Cope Family Medicine
Bountiful, Utah, 84010
The Derm Institute of West Michigan
Caledonia, Michigan, 49316
Hope Clinical Research LLC
Canoga Park, California, 91303
Medical University of South Carolina
Charleston, South Carolina, 29425
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, 73018
Doc1 Healthcare Systems
Chino, California, 91710
Alliance for Multispecialty Research
Coral Gables, Florida, 33134
Life Clinical Trials
Coral Springs, Florida, 33071
AllerVie Clinical Research- Destin
Destin, Florida, 32541
D and H Doral Research Centers
Doral, Florida, 33122
Saint Jude Clinical Research
Doral, Florida, 33172
First Georgia Physicians Group
Fayetteville, Georgia, 30214
Cumberland Skin Center
Hermitage, Tennessee, 37076
Direct Helpers Research Center
Hialeah, Florida, 33012
Hickory Dermatology Research Center
Hickory, North Carolina, 28602
Nexus Clinical Research
Homestead, Florida, 33033
MedCare Pharma - Houston
Houston, Texas, 77037
Indiana University School of Medicine
Indianapolis, Indiana, 46202
310 Clinical Research
Inglewood, California, 90301
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Chemidox Clinical Trials Incorporated
Lancaster, California, 93534
Visage Dermatology and Aesthetic Center
Largo, Maryland, 20774
Excel Clinical Research
Las Vegas, Nevada, 89109
Dermatology and Skin Cancer Center Leawood
Leawood, Kansas, 66211
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, 72205
Long Beach Research Institute
Long Beach, California, 90805
University of California Los Angeles
Los Angeles, California, 90024
Wallace Medical Group Inc
Los Angeles, California, 90056
West Los Angeles Clinical Trials
Los Angeles, California, 90067
Dermatologic Surgery Specialists
Macon, Georgia, 31217
Tryon Medical Partners
Matthews, North Carolina, 28105
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124
Velocity Clinical Research Inc
Medford, Oregon, 97504
sms Clinical Research Limited Liability Company
Mesquite, Texas, 75149
ActivMed Practices and Research, LLC
Methuen, Massachusetts, 01844
D and H National Research Centers
Miami, Florida, 33155
Gold Coast Health Research Center
Miami, Florida, 33155
Anchor Medical Research
Miami, Florida, 33176
Meridian International Research
Miami Gardens, Florida, 33014
Tanner Clinic
Murray, Utah, 84107
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
Pioneer Clinical Research New York
New York, New York, 10016
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
Northridge Clinical Trials
Northridge, California, 91325
AllerVie Clinical Research- Ocala
Ocala, Florida, 34471
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Havana Research Institute Inc
Pasadena, California, 91105
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
Rochester Clinical Research Inc
Rochester, New York, 14609
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Integrative Skin Science and Research
Sacramento, California, 95815
Wake Research Medical Center for Clinical Research
San Diego, California, 92120
Affiliated Dermatology
Scottsdale, Arizona, 85255
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, 85260
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
Cura Clinical Research
Sherman Oaks, California, 91403
Stryde Research - Epiphany Dermatology
Southlake, Texas, 76092
Dermatologist of Central States Clinical Research - Springfield
Springfield, Ohio, 45505
D and H Tamarac Research Centers
Tamarac, Florida, 33321
Medical Advancement Centers of Arizona
Tempe, Arizona, 85283
McIntosh Clinic PC
Thomasville, Georgia, 31792
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, 74132
Wolverine Clinical Trials
Tustin, California, 92780
Tranquil Clinical Research
Webster, Texas, 77598
The Skin Surgery Center
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada13 sites

Skin Physicians Dermatology
Edmonton, Alberta, T6W 4V4
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Interior Dermatology Centre
Kelowna, British Columbia, V1W 4V5
Clinique de Dermatologie Rosemont
Montreal, Quebec, H1Y 3L1
Centre de Recherche Saint-Louis
Québec, Quebec, G1W 4R4
York Dermatology Centre
Richmond Hill, Ontario, L4C 9M7
Karma Clinical Trials
St. John's, Newfoundland and Labrador, A1A 4Y3
Skincare Studio
St. John's, Newfoundland and Labrador, A1E 1V4
FACET Dermatology
Toronto, Ontario, M4E 1R7
Evidence Based Medical Educator Inc
Toronto, Ontario, M5G 1E2
DermAtelier Clinical Research Incorporated
Toronto, Ontario, M5M 3Z8
Sima recherche
Verdun, Quebec, H4G 3E7

Other trials in Canada

About this study

Official title: A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

The primary objectives of this study are to:

estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24
estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24

Conditions: Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
Being tested: Rocatinlimab, Placebo
Keywords: Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RocatinlimabDrug
Also called AMG 451, KHK4083
Subcutaneous (SC) injection
PlaceboDrug
SC injection

Study groups in NCT05899816
Study group	Role	What they receive
Rocatinlimab	Experimental	Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. Receives: Drug: Rocatinlimab
Placebo	Placebo comparator	Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Positive Anti-tetanus Response at Week 24
Participants received 1 dose of a tetanus vaccine at Week 20. The antibody response to the tetanus vaccine was assessed by measuring serum anti-tetanus immunoglobulin G (IgG) by an immunoassay.
Measured: Week 20 to Week 24
Percentage of Participants With a Positive Anti-meningococcal Response at Week 24
Participants received 1 dose of a meningococcal vaccine at Week 20. The antibody response to the meningococcal vaccine was assessed by measuring serum anti-meningococcal IgG by an immunoassay.
Measured: Week 20 to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 202314 Nov 2024

First posted12 Jun 2023
Study start7 Jun 2023
Primary completion26 Aug 2024
Study completion14 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05899816
Sponsor's protocol ID: 20210158
Acronym: ROCKET-VOYAGER
Status last verified: Jun 2026
First submitted: 2 Jun 2023
Last updated: 23 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
PubMed 40012373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
ClinicalTrials.gov ID: NCT05899816
Acronym / sponsor ID: ROCKET-VOYAGER / 20210158
Conditions: Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
Keywords: Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 7 Jun 2023 (actual)
Primary completion: 26 Aug 2024 (actual)
Study completion: 14 Nov 2024 (actual)
First posted: 12 Jun 2023 (actual)
Results: Posted 23 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objectives of this study are to:

estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24
estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Rocatinlimab	Experimental	Drug: RocatinlimabRocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Placebo	Placebo comparator	Drug: PlaceboPlacebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Who may qualify

Ages: 18 to 54 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months
History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)
Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3

Key exclusion criteria (14 listed)

Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization.
Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RocatinlimabAlso: AMG 451, KHK4083Subcutaneous (SC) injection	Drug	Rocatinlimab
PlaceboSC injection	Drug	Placebo

Primary outcome

Percentage of Participants With a Positive Anti-tetanus Response at Week 24
Time frame: Week 20 to Week 24
Participants received 1 dose of a tetanus vaccine at Week 20. The antibody response to the tetanus vaccine was assessed by measuring serum anti-tetanus immunoglobulin G (IgG) by an immunoassay.
Percentage of Participants With a Positive Anti-meningococcal Response at Week 24
Time frame: Week 20 to Week 24
Participants received 1 dose of a meningococcal vaccine at Week 20. The antibody response to the meningococcal vaccine was assessed by measuring serum anti-meningococcal IgG by an immunoassay.

Results and safety

Results posted to the registry on 23 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	68	58
Rocatinlimab	128	113

Primary outcome: Percentage of Participants With a Positive Anti-tetanus Response at Week 24

Time frame: Week 20 to Week 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 52	Rocatinlimab n = 105
Value	92.3 (81.5 to 97.9)	87.6 (79.8 to 93.2)

Placebo vs Rocatinlimab: Risk Difference (RD): -4.7 (95% CI -13.5 to 5.9), Mantel Haenszel

Population analysed: Tetanus Vaccine Immune Response Analysis Set: Participants who missed no more than one dose of investigational product before vaccine administration at Week 20 and had anti-tetanus IgG antibody samples collected and reported at both Week 20 and Week 24.

Primary outcome: Percentage of Participants With a Positive Anti-meningococcal Response at Week 24

Time frame: Week 20 to Week 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 47	Rocatinlimab n = 99
Value	53.2 (38.1 to 67.9)	52.5 (42.2 to 62.7)

Placebo vs Rocatinlimab: Risk Difference (RD): -0.7 (95% CI -18.3 to 17.1), Mantel Haenszel

Population analysed: Meningococcal Vaccine Immune Response Analysis Set: Participants who missed no more than one dose of investigational product before vaccine administration at Week 20 and had anti-meningococcal IgG antibody samples collected and reported at both Week 20 and Week 24.

Adverse events

Time frame: For mortality reporting, from randomization until the end of trial; median (min, max) time on trial was 24.4 (2.1, 42.3) weeks. For TEAE reporting, from first dose of trial drug until the end of trial; median (min, max) duration was 24.4 (2.1, 42.3) weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 68 (0%)	4 of 68 (5.9%)	0 of 68
Rocatinlimab	3 of 128 (2.3%)	18 of 128 (14.1%)	0 of 128

Limitations and caveats (from the sponsor): 25 participants enrolled were excluded from all efficacy and safety analyses due to site-wide serious breaches and good clinical practice violations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 40012373Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Related trials for Atopic Dermatitis

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Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
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A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
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RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

85 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis and Moderate-to-severe Atopic Dermatitis, run by Amgen at 85 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Positive Anti-tetanus Response at Week 24 (time frame: Week 20 to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05899816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.